Voluntary HIV counseling and testing (VCT) and anti-HIV drugs for pregnant women and their newborns decrease rates of mother-to-child transmission (MTCT) of HIV. This study will determine the acceptability of HIV counseling and rapid testing prior to delivery and will compare the usefulness of VCT prior to birth versus after birth in preventing MTCT of HIV in pregnant women in Cape Town, South Africa. This study will also determine the acceptability and effectiveness of giving anti-HIV medications to prevent MTCT of HIV.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Time required to obtain informed consent

time from initiation of HIV pre-test counseling until test results are available

proportion of test evaluations completed before delivery

proportion of test evaluations completed before hospital discharge

proportion of women who agree to HIV testing

proportion of women identified as HIV infected during labor who accept ARV prophylaxis

proportion of women identified as HIV infected after birth who accept ARV therapy for their infants

timing of infant ARV prophylaxis initiation after birth, as a proportion of infants born to women identified as HIV infected after birth and as a continuous variable

timing of mother ARV initiation as a proportion of women identified as HIV infected during labor and as a continuous variable

qualitative measures (defined as available space, study staff allocation, support for counseling and testing, and women's perceptions and opinions of counseling and testing)

Secondary Outcome Measures:

Proportion of women with undocumented HIV infection who are tested and determined to be HIV infected peripartum

performance of rapid HIV tests as measured by sensitivity and specificity

proportion of infants who complete the Week 6 study visit and efforts needed to accomplish this visit

proportion of infants being fed according to the method chosen at discharge (defined as exclusive breastfeeding, exclusive formula feeding, or mixed feeding), as reported by the mother at Week 6

proportion of HIV-exposed infants who acquire HIV infection during delivery and after birth

acceptance of HIV counseling and testing among clinical personnel at primary, secondary, and tertiary care facilities

Enrollment:

283

Study Start Date:

November 2004

Study Completion Date:

December 2006

Detailed Description:

Pediatric HIV infection is a major public health problem in South Africa, and is primarily caused by MTCT of HIV. Strategies to prevent MTCT have been successfully employed when a mother's HIV status is known. However, there is concern in South Africa that it is unethical to offer HIV testing to women in the intrapartum period when they are experiencing the physical and emotional stress of labor. This study will compare the acceptability and accuracy of intrapartum and postpartum VCT in pregnant women of unknown HIV status in Cape Town, South Africa.

Pregnant women of unknown HIV status coming to a participating hospital to deliver will be asked to enter the trial. Women will be assigned to either intrapartum or postpartum VCT depending on the week during which they come to the hospital. The intervention (intrapartum or postpartum VCT) for the week will be randomly assigned and all women enrolling in the trial in a given week will receive the same intervention.

All women will receive HIV counseling prior to testing. Women in the intrapartum VCT group who are HIV infected will receive antiretrovirals (ARV) prior to delivery to prevent MTCT, and their infants will receive ARV within 3 days of birth. Infants born to HIV infected women in the postpartum VCT group will receive ARV as soon as possible after confirmation of the mother's positive test. All women will receive post-test counseling prior to discharge.

HIV VCT, medical history assessment, and physical exam will occur at study entry. A small subset of both HIV infected and uninfected mothers will be asked for their opinions regarding peripartum HIV VCT and MTCT prevention strategies during qualitative assessments.

Infants will undergo physical exam within 2 days of birth, medical history assessment within 2 days of birth and at 3 additional times between 6 and 14 weeks of age, and HIV testing within 2 days of birth and at 2 additional times between 6 and 12 weeks of age.

Eligibility

Ages Eligible for Study:

14 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria for Women:

Unknown HIV infection status

At least seven months pregnant

Women in active labor who have planned induction or Caesarean delivery or any other condition requiring planned delivery

Inclusion Criteria for Infants:

Mother is participating in study

Mother is HIV infected

Exclusion Criteria for Women:

Women in labor who need immediate delivery

Obstetrical emergencies in which the woman is medically unstable or requires emergency delivery

Diagnosed fetal death or fetal condition requiring abortion

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084045